A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)

What this Trial Is About

Researchers are evaluating the safety, tolerability, and potential effectiveness of multiple subcutaneous injections of APL-9796 in adults with pulmonary hypertension (PH) in this phase 2, open-label dose escalation trial. The study focuses on adults diagnosed with WHO Group 1 Pulmonary Arterial Hypertension (PAH) and optionally includes adults with WHO Group 3 PH associated with interstitial lung disease (PH-ILD). The trial also monitors whether the body produces antibodies against APL-9796. The study is conducted in two parts with different participant groups. Part A involves up to 36 adults with WHO Group 1 PAH receiving one of three planned dose levels of APL-9796, evaluated sequentially in cohorts of four participants. An optional Part B may include up to 12 adults with WHO Group 3 PH-ILD, with initiation decided by a Safety Review Committee. The treatment is given as subcutaneous injections, and dose levels are adjusted based on ongoing safety data. Participants will be assessed through various evaluations including telemetry parameters, six-minute walk tests, NT-proBNP blood tests, and quality of life questionnaires from baseline through day 169. Pharmacokinetics and immune response to APL-9796 will be monitored at regular visits approximately every 28 days until day 169, with additional follow-ups on days 254, 339, and 508. The primary outcome focuses on the incidence of treatment-emergent adverse events over about two years, ensuring thorough safety and tolerability monitoring throughout the study.

A Trial of "APL-9796'' in Adults With Pulmonary Hypertension